Surgical needle device

ABSTRACT

Various surgical introducer needle and anchor systems are provided. The systems can include an introducer needle and a tissue support implant or sling device. The implant device can include one or more anchoring devices. The introducer needle device can include a handle assembly and a needle assembly. The needle assembly can include a generally hollow needle, and a wire traversable therein. The wire can include a distal tip adapted to selectively retract or withdraw from the engaged anchoring device upon deployment of the anchor and/or implant.

RELATED APPLICATIONS

This application claims priority to and is a Continuation Application ofU.S. patent application Ser. No. 12/606,758, filed Oct. 27, 2009, issuedas U.S. Pat. No. 8,944,990, which claims priority to and the benefit ofU.S. Provisional Application No. 61/108,686 filed Oct. 27, 2008, U.S.Provisional Application No. 61/173,396 filed Apr. 28, 2009, and U.S.Provisional Application No. 61/186,616 filed Jun. 12, 2009, each ofwhich are incorporated fully herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to surgical methods andapparatus and, more specifically, to a surgical needle adapted toselectively engage one or more implant anchors, such as those used foranchoring to soft tissue.

BACKGROUND OF THE INVENTION

Pelvic health for men and women is a medical area of increasingimportance, at least in part due to an aging population. Examples ofcommon pelvic ailments include incontinence (fecal and urinary), pelvictissue prolapse (e.g., female vaginal prolapse), and conditions of thepelvic floor.

Urinary incontinence can further be classified as including differenttypes, such as stress urinary incontinence (SUI), urge urinaryincontinence, mixed urinary incontinence, among others. Other pelvicfloor disorders include cystocele, rectocele, enterocele, and prolapsesuch as anal, uterine and vaginal vault prolapse. A cystocele is ahernia of the bladder, usually into the vagina and introitus. Pelvicdisorders such as these can result from weakness or damage to normalpelvic support systems.

In its severest forms, vaginal vault prolapse can result in thedistension of the vaginal apex outside of the vagina. An enterocele is avaginal hernia in which the peritoneal sac containing a portion of thesmall bowel extends into the rectovaginal space. Vaginal vault prolapseand enterocele represent challenging forms of pelvic disorders forsurgeons. These procedures often involve lengthy surgical proceduretimes.

Urinary incontinence can be characterized by the loss or diminution inthe ability to maintain the urethral sphincter closed as the bladderfills with urine. Male or female stress urinary incontinence (SUI)occurs when the patient is physically stressed.

A specific area of pelvic health is trauma of the pelvic floor, e.g., ofthe levator (“levator ani”) or coccygeus muscle (collectively the pelvicfloor). The pelvic floor is made up of the levator and coccygeusmuscles, and the levator is made up of components that include thepuborectalis muscle, the pubococcygeus muscle, and the iliococcygeousmuscle. For various reasons, the levator may suffer weakness or injurysuch as damage to the levator hiatus, ballooning or levator avulsion,any of which that can result in symptoms such as prolapse, fecalincontinence, and other conditions of the pelvis.

Levator defects (weakness or injury) can affect any portion of thelevator, and can be especially common in the pubic portion of thelevator ani, including the pubococcygeus and puborectalis muscles. Suchdefects are relatively common, for instance, in women with vaginalprolapse. Defects can also be present at the iliococcygeus muscle. Stillother defects are in the form of a paravaginal defect, such as avulsionof the inferiomedial aspects of the levator ani from the pelvicsidewall; avulsion can refer to tissue being detached from the pubicbone, and may precede prolapse conditions. Another levator defect islevator ballooning, which refers to distension of levator muscles.

A different levator defect is a defect of the levator hiatus, which canreduce the stability of the pelvic floor and may result in sexualdysfunction, defecatory dysfunction, rectal prolapse, and fecalincontinence. Levator hiatus is also believed to play a significant rolein the progression of prolapse.

There is a desire to obtain a minimally invasive yet highly effectiveneedle and anchoring system that can be used to treat incontinence,pelvic organ prolapse and other conditions.

SUMMARY OF THE INVENTION

In one embodiment, a surgical introducer needle and anchor kit or systemincludes an implantable support apparatus, such as a sling, mesh orstraps, a needle assembly having a retractable wire and handle assembly,and one or more anchoring devices generally attached at one or more endsof the support apparatus. Each anchor device is adapted for attachmentto tissue within the pelvis of a patient such that attachment to thepatient tissue allows for selective placement of the support apparatusto support the patient's bladder, urethra or other organs or tissue. Thehandle and needle assemblies are adapted to operatively and selectivelyengage and direct the anchors and support apparatus of the system.

The needle and anchoring assemblies can be configured to provideincreased precision, reliability and usefulness in engaging an anchordevice or implant, and retracting the needle, or a portion thereof, fromthe anchor upon deployment. Various embodiments of the needle system ofthe present invention can include a handle operatively coupled with acannulated needle and an internal wire or like structure such that adistal tip of the wire is selectively engageable with and retractablefrom the implant or anchor. The internal wire and the respective distaltip can be retractable within the needle by way of at least oneactuator, e.g., a slider actuator.

Other embodiments of the handle assembly can include a lock-out assemblyto limit back travel of the wire distal tip during deployment, with thetip being capable of retraction upon use of the at least one actuator.

Still other embodiments of the handle assembly can include a clicker ortoggle mechanism as the at least one actuator to selectively toggleretraction and extension of the wire distal tip.

Various anchor systems can be included to provide security so that theanchor will not easily detach or disengage from the needle duringinsertion, while still allowing for accurate placement and detachment ofthe anchor from the needle during deployment of the anchor e.g., withinsoft tissue within the pelvic region of a patient. For instance,retraction of the needle, or a portion thereof, from the anchor promotesstable and accurate positioning because the anchor is not forced orpushed off of the needle device (causing positional movement or shiftingof the anchor). Instead, the anchor is securely seated in abutablecontact with the needle (e.g., the barb guard) such that retraction ofthe needle or wire does not generally alter the angle, positioning orlocation of the anchor.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a surgical introducer needle and anchorsystem in accordance with embodiments of the present invention.

FIG. 2 is a top view of a surgical introducer needle and anchor systemin accordance with embodiments of the present invention.

FIG. 3 is a side view of a surgical introducer needle and anchor systemin accordance with embodiments of the present invention.

FIG. 3a is a schematic cross-section view of the surgical introducerneedle and anchor system at line 3 a-3 a of FIG. 3.

FIG. 4 is a schematic view of a surgical introducer needle and anchorsystem, with a lock-out assembly, in accordance with embodiments of thepresent invention.

FIG. 5 is a schematic view of a surgical introducer needle and anchorsystem, with a lock-out assembly, in accordance with embodiments of thepresent invention.

FIG. 5a is a schematic view of a surgical introducer needle and anchorsystem, with a lock-out assembly, in accordance with embodiments of thepresent invention.

FIG. 5b is a schematic view of a surgical introducer needle and anchorsystem, with a lock-out assembly, in accordance with embodiments of thepresent invention.

FIG. 6 is a top schematic view of a needle assembly in accordance withembodiments of the present invention.

FIG. 7 is a side schematic view of a needle assembly in accordance withembodiments of the present invention.

FIG. 8 is a top schematic view of an actuator wire in accordance withembodiments of the present invention.

FIG. 9 is a side schematic view of wire distal tip portion in accordancewith embodiments of the present invention.

FIG. 10 is a side schematic cross-section view of an actuator wirecoupled with a distal tip portion in accordance with embodiments of thepresent invention.

FIG. 11 is a top schematic view of a handle actuator in accordance withembodiments of the present invention.

FIG. 12 is a top schematic view of a needle assembly and handle actuatorin accordance with embodiments of the present invention.

FIG. 13 is a front schematic cross-section view of an alignment portionand needle in accordance with embodiments of the present invention.

FIG. 14 is a schematic view of a distal needle portion and wire tip inaccordance with embodiments of the present invention.

FIG. 15 is a top schematic view of a distal needle portion, wire tip andanchor device in accordance with embodiments of the present invention.

FIG. 16 is a top schematic view of a distal needle portion, wire tip andanchor device in accordance with embodiments of the present invention.

FIG. 17 is a top schematic view of a sling implant with end anchordevices in accordance with embodiments of the present invention.

FIG. 18 is a schematic view of a sling implant coupled with an endanchor device in accordance with embodiments of the present invention.

FIG. 19 is a perspective view of a surgical introducer needle and anchorsystem having a toggle mechanism in accordance with embodiments of thepresent invention.

FIG. 20 is a schematic view of a surgical introducer needle and anchorsystem having a toggle mechanism in accordance with embodiments of thepresent invention.

FIG. 21 is a schematic view of a surgical introducer needle and anchorsystem having a toggle mechanism in accordance with embodiments of thepresent invention.

FIG. 22 is a schematic cross-section view of a wedge fit needle andanchor system in accordance with embodiments of the present invention.

FIGS. 23-24 are schematic cross-section views of a snap fit needle andanchor system in accordance with embodiments of the present invention.

FIGS. 25-26 are schematic views of a split tip and wedge needle andanchor system in accordance with embodiments of the present invention.

FIGS. 27-28 are schematic views of a tube and wedge lock needle andanchor system in accordance with embodiments of the present invention.

FIGS. 29a-31b are schematic views of a locking barb needle and anchorsystem in accordance with embodiments of the present invention.

FIGS. 32a-32c are schematic views of a snap fit needle and anchor systemin accordance with embodiments of the present invention.

FIGS. 33-34 are schematic views of a squeeze lock needle and anchorsystem in accordance with embodiments of the present invention.

FIG. 35 is a schematic view of a limited press fit needle and anchorsystem in accordance with embodiments of the present invention.

FIGS. 37-38 are schematic views of one-sided and regional press fitneedle and anchor systems in accordance with embodiments of the presentinvention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring generally to FIGS. 1-21, various embodiments of surgicalintroducer needle and anchor systems 10 are shown. In general, thesystems 10 can include a needle device and a tissue support implant orsling device. The implant device can include one or more anchoringdevices. The anchoring devices can be referred to as self-fixatinganchors or tips. The introducer needle device can include a handleassembly 18 and a needle assembly 20. The systems 10 can be adapted foruse to anchor implants in females to support tissue to treatincontinence, prolapse or other pelvic health conditions. The presentinvention may be used to correct central defects, midline defects, bothmidline and central defects at once, as well as other like conditions.Further, the various components of the systems 10 can be constructed ofmaterials such as polymers, metals, and other like materials compatiblefor use with surgical needle, handle, and anchor devices and systems asknown to one of ordinary skill in the art.

The various systems 10, features and methods detailed herein areenvisioned for use with many known implant and repair systems (e.g., formale and female), features and methods, including those disclosed inU.S. Pat. Nos. 7,351,197 and 6,691,711, International Patent PublicationNos. WO 2008/057261 and WO 2007/097994, U.S. Patent Publication Nos.2002/151762 and 2002/147382, and International Patent Application SerialNo. PCT/US2008/009066, filed Jul. 25, 2008. Accordingly, theabove-identified disclosures are incorporated herein by reference intheir entirety.

Referring generally to FIGS. 1-18, embodiments of the handle assembly 18and the retractable needle assembly 20 are shown. The handle 18 can beprovided in a clam-shell configuration, and can be constructed ofpolymer materials, metals and other materials known to those of ordinaryskill in the art. The handle 18 can be configured to include a firstportion of 18 a and a second portion or 18 b adapted to snap orotherwise fasten or couple to one another. Various known fastener,fitting, boss and post, and like attachment configurations andtechniques can be employed to join or attach the portions 18 a, 18 b ofthe handle 18 together. The handle assembly 18 can further include oneor more actuators 34, e.g., two actuator sliders 34 a, 34 b, which canbe slid, pressed, or otherwise engaged to extend and retract at least aportion of the needle assembly 20. Disposed within a cavity or otherportion of the handle assembly 18 is a biasing member 36, such as aspring. As detailed herein, the biasing member 36 biases the one or moreactuators 34 in the extended position in one embodiment.

Each housing portion 18 a, 18 b can include a neck portion 22, andchannels or recesses 24. When the housing portions 18 a, 18 b arecoupled, the recesses 24 define openings 26 adapted to provide spacingfor the actuators 34 a, 34 b to traverse or slide along or within, withat least a portion of the actuators 34 a, 34 b extending out from theopenings 26. Similarly, coupling of the housing portions 18 a, 18 bjoins the neck portions 22 to define an opening for shrouding a portionof the needle assembly 20.

The needle assembly 20 can include an elongate cannulated needle 40having a proximal end 42 and an engagement tip or distal end 44, with alumen 43 extending therethrough, as illustrated in FIGS. 6-7. Theproximal end 42 is adapted for interfitting with or operativelyconnecting to the handle assembly 18. As such, the proximal end 42 caninclude an alignment portion 45, such as an alignment block, adapted torest or otherwise align and secure the proximal end 42 within the handleassembly 18 or its components, generally maintaining the needle 40 in astationary position during use.

In one embodiment, at least a portion of the needle 40 is generallycurved or arcuate (e.g., FIGS. 1, 3 and 7) to facilitate pelvicintroduction and maneuverability. The needle 40 can be configured tohave an overall length of between about 4 inches and 6 inches, with agenerally straight portion between 3 inches and 4 inches, and a curvedportion extending the rest of the length to the distal end 44. Such aneedle 40 design can have an outer diameter of about 0.07 inches to 0.10inches, with various inner diameters envisioned for the lumen 43 (e.g.,approximately 0.030 inches). However, in other embodiments the needle 40can be generally straight along its entire length, or can take on avariation of other known shape and size configurations. The needle 40,or portions thereof, can be constructed of compatible polymers ormetals, including stainless steel. Within the housing assembly 18, theproximal end 42 of the needle 40 can extend through and past thealignment portion 45, and be secured or configured to restrictrotational movement of the needle 40.

Further, as shown in FIGS. 8-10, the needle assembly 20 can include anactuator wire 50 capable of traversing at least along a portion of theinner diameter of the needle lumen 43. The wire 50, or portions thereof,can be constructed of compatible polymers or metals, including stainlesssteel. The wire 50 includes a wire proximal portion 52 and a wire distalportion or tip 54. The wire proximal portion 52 is adapted tooperatively interface or connect with components or structures withinthe handle assembly 18, such as a portion of the one or more actuators34. In one embodiment, the wire distal portion or tip 54 can be aseparate member coupled with an end of the wire 50. For instance, thedistal tip 54 can be measurably larger in diameter than the wire 50diameter, including a coupling channel or recess 54 a defined therein toreceive and secure the relatively thinner wire 50 (FIGS. 9-10). The wire50 is retractable and extendable along a distance of the lumen 43 suchthat the wire distal portion 54 is capable of extending out of or fromthe distal end 44 of the needle 40 and lumen 43. In other embodiments,the wire 50 or at least a portion of the wire 50 can be disposed alongor traverse the outside of the needle, such as through a sleeve externalto the needle, along the outside length of the needle, through or alonga lumen or structure generally separate or distinct from the needle,etc.

As provided herein, the alignment portion 45 can be adapted to mate orcouple with a portion of the proximal end 42 of the needle 40 forintegration within the handle assembly 18, as shown in FIG. 12. Forinstance, in one embodiment, the alignment portion 45 can be generallyH-shaped with a lumen 47 defined therein to receive the proximal end 42of the needle 40. As such, receiving channels 49 can be provided withinthe alignment portion 45 to slidably receive portions of the actuator34.

In an embodiment as depicted in FIGS. 11-13, the one or more actuators34 can be constructed to include two actuators 34 a, 34 b, body portions35, a proximal base 37, and a gap 39. The body portions 35 can extendinto the housing 18 from respective actuators 34 a, 34 b to define thegap 39 therebetween. The proximal base 37 can be adapted to receive theproximal portion 52 of the wire 50, e.g., by crimping or otherwisesecuring the proximal portion 52 of the wire 50 to a portion of theproximal base 37 (FIG. 12). In one embodiment, the proximal portion 52of the wire 50 can be crimped at a securing portion 37 a of the proximalbase 37. Further, the proximal base 37 can include a bore or recesstherein to receive at least an end region of the biasing member 36, withthe other end region abutting against one or more structures within atleast one of the handle halves 18 a, 18 b.

The body portions 35 extending from the actuators 34 a, 34 b can bedisposed within or extend into the corresponding receiving channels 49of the alignment portion 45 of the needle 40 as a guiding feature, suchthat the respective body portions 35 can slide within the receivingchannels 49, with the alignment portion 45 remaining substantiallystationary. In such a configuration, the body portions 35 can slidewithin or along the channels 49 upon activation or engagement by an enduser of the actuators 34 a, 34 b, while still maintaining placement andsecurement of the components within the handle assembly 18. Accordingly,the needle 40 is generally secured and the wire 50, coupled to theproximal base 37 (e.g., at portion 37 a) of the actuators, is adapted tocorrespondingly travel with the actuators 34 a, 34 b. Otherconfigurations and designs for the handle assembly 18, including itssliding, guiding and coupling components, can be employed as wellwithout deviating from the spirit and scope of the invention.

Referring generally to FIGS. 4-5, and 14-16, when the actuators 34 a, 34b are in an extended position, e.g., generally away from the handleassembly 18, the wire distal portion 54 is also in an extended orengageable position, e.g., generally away from the needle 40 distal end44 (e.g., extending out of the lumen 43). Likewise, when the actuators34 a, 34 b are slid or otherwise moved toward the handle assembly 18into a disengagement position, the wire 50 and the corresponding wiredistal portion 54 retracts toward or into the needle 40 distal end 44(e.g., into the lumen 43).

The wire distal portion or tip 54 is adapted and configured to engagewith an anchor 16, as shown in FIGS. 15-18. The anchor 16 can be anyfixating, or self-fixating, tissue anchor provided at ends of a slingimplant 17 (e.g., mesh or other known tissue support structures). Theanchors 16 of the implant 17 are adapted for attachment within orthrough target tissue of the pelvic region of a patient, including thosedisclosed herein and in the incorporated references.

In the extended position, the wire distal portion 54 can be slid orsnapped into engagement with the anchor 16. The anchor 16 and/or thewire distal portion 54 can include features to facilitate engagement andretention of the anchor 16 until the wire distal portion 54 is retractedaway from engagement with the anchor 16. In one embodiment, the wiredistal portion 54 is shaped and sized (e.g., tapered, bulbous, etc.) toextend into an internal channel or bore 60 within the anchor 16 forforceable or otherwise mateable engagement with the anchor 16. At leasta portion of the wire distal portion 54 can be extendable out a distancefrom the engaged anchor 16 (FIG. 15). Upon retraction of the actuators34 a, 34 b, and correspondingly the wire distal portion 54, the anchor16 is generally freed of engagement with the needle 40 and itscomponents. Other embodiments configured to facilitate selectiveengagement of the anchor 16 with the wire distal portion 54 or needledistal end 44 are disclosed in greater detail herein.

The needle assembly 40 can further include a barb guard 64 providedproximate the distal end 44, as depicted in FIGS. 15-16. The barb guard64 can include a coupling portion 67 and one or more extending members65. The barb guard 64 can be shaped and configured to interface withextending tines 61 of the anchor 16. For instance, the barb guard 64 caninclude one or more extending members 65. The extending members 65 canbe straight, curved, flared and/or angled, or can take on a myriad ofother compatible configurations. The barb guards 64 can prevent thetines 61 from engaging tissue until the wire distal portion 54 isdisengaged from the anchor 16, and can provide an abutment surface forthe anchor 16 when the wire distal portion 54 is retracted or pulledback to disengage the anchor 16 with activation of the one or moreactuators 34 a, 34 b.

In one embodiment, as shown in FIGS. 4-5 b, the handle assembly 18includes a lock-out assembly 70. The lock-out assembly 70 generallyprovides a feature in the handle 80 adapted to resist retraction or backtravel of the distal tip 54 during deployment, or until the actuators 34a, 34 b are engaged to retract the tip 54. Such a feature can bebeneficial to keep the tip 54 from retracting during docking of theanchor 16 onto the tip 54. Further, such a feature can be beneficial inthose procedures where the tip 54 may come into forceable contact withbone, device or implant structures, or other solid or unforgivingsurfaces, thereby preventing the tip 54 from retracting until deploymentof the anchor 16 is intended.

The lock-out assembly 70 can include a body portion 71 and an abutmentfeature 75. The body portion 71 includes one or more wing members 72. Inone embodiment, the wing members 72 flare out at an angle, with wingtips 74 a, 74 b defined at ends of the members 72. The wing members 72can be constructed of a material, e.g., polymer or metal, with at leasta measurable level of flexibility such that the wing members 72 candeform, bend, pivot or otherwise move at least a small distance intoward the body portion 71. The abutment feature 75 can be defined byone or more wall portions provided with, or a recess provided within,the alignment portion 45, such as the proximal base 37 (FIG. 5a ). Thewalls of the feature 75 can be angled in proximity to the positionedwing members 72. As such, the body portion 71 is seated within oradjacent the abutment feature 75. Further, the wing tips 74 a, 74 bextend out from a portion or surface of the alignment portion 45 toengage corresponding structures in at least one of the handle portions18 a, 18 b (FIG. 5b ). For instance, the wing tips 74 a, 74 b can besized and shaped to engage notches, grooves or other structures in thehandle portions 18 a, 18 b.

In an initial seating position, where the tip 54 is extended from theneedle 40, the body portion 71 is seated within the abutment feature 75,the wing members 72 are relaxed or fully extended, and the wing tips 74a, 74 b are engaged with respective portions of the handle 18. In thisinitial position, pressure on the needle tip 54, without engagement ofthe actuators 34 a, 34 b, will be resisted to generally prevent backtravel or retraction. Namely, the wing tips 74 a, 74 b resist movementbackward according to their seated position within the mating structureof the handle 18 and, therefore, the operatively coupled distal tip 54will not retract. However, upon engagement of the actuators 34 a, 34 btoward the handle 18, the alignment portion 45 will begin moving which,in turn, moves the included abutment feature 75 surrounding the bodyportion 71. As a result, the angled walls of the feature 75 will beginto contact the wing members 72. This pressure on the wing members 72will cause them to at least slightly deform or bend inward so that thewing tips 74 a, 74 b likewise move inward until the point where theyrelease from the structures in the housing 18 where they were initiallyseated or secured. With the tips 74 a, 74 b released from a securedposition, the actuators 34 a, 34 b are free to move, along with thecorresponding body 35 and base 37 portions of the actuators, to retractthe operatively coupled distal tip 54.

Other embodiments of the system 10, such as that depicted in FIG. 3a ,can be constructed without the lock-out assembly 70 described herein.

In general use, the actuators 34 a, 34 b of the handle assembly 40 caninitially be in an extended or engageable position such that the wiredistal portion 54 is also in an extended/engageable position (FIGS. 3-4and 14). As such, the anchor 16, e.g., a soft tissue anchor, can beinserted, fitted, snapped, or otherwise coupled to the distal end 54(FIG. 15). As stated, a mesh, sling or support device or structure 17can be connected with the tissue anchor 16 (FIGS. 17-18). The needle 40,distal end 54 and tissue anchor 16 are inserted into the pelvic regionof a patient to a target tissue location where the anchor 16 can beinserted into or through the target tissue. The user can then activateor engage the actuators 34 a, 34 b to slide the actuators toward thehandle assembly 18 (FIG. 5). This, in turn, compresses the biasingmember 36 and causes the wire 50 to retract such that the distal portion54 corresponding withdraws (FIGS. 5 and 16). In certain embodiments,activation of the actuators 34 a, 34 b further disengages the lock-outassembly 70 to permit retraction of the distal portion 54 (FIGS. 5a-5b). At a point in the retraction, the distal portion 54 withdraws throughthe anchor bore 60, thereby disengaging or pulling away from the anchor16, leaving the anchor 16 in the target tissue with the mesh, sling orother support device 17 or structure anchored. An audible click orreverb in the handle 18 can provide an indication to the user that theanchor 16 and wire distal portion 54 are disengaged. This process can berepeated for multiple anchor 16 insertions and target tissue anchoringprocedures.

Other embodiments of the system 10 can include a clicker or togglemechanism 80 adapted to selectively extend and retract the wire distalportion 54 within the needle 40. For instance, the toggle mechanism 80can be operatively coupled to the handle assembly 18 and needle assembly16. The toggle mechanism 80 can include a housing 82 and an actuator 84,with the toggle mechanism 80 being provided with, and at least partiallyhoused within, the handle assembly 18. The mechanism 80 can beconfigured in accordance with other embodiments described herein,wherein the mechanism 80 serves to replace the actuators 34 a, 34 b suchthat activation of the actuator 84 controls respective extension andretraction of the wire distal portion 54. In such an embodiment, theneedle 20, wire 50, and handle 18 components from previously-detailedembodiments can be employed, all or in part.

The toggle mechanism 80 employed with various embodiments of the presentinvention can resemble or simulate known rotational locking mechanismimplemented in various writing pen products. For instance, pressing ofthe actuator 84 causes an operatively coupled member (e.g., needle 90)to toggle between an extended and retracted position.

Other embodiments employing a toggle mechanism, as shown in FIGS. 19-21,can resemble that of the previous embodiments described herein. However,these embodiments can include a generally solid needle 90 (e.g., ratherthan hollow), a handle assembly 92 and a tubular member 94. The handleassembly 92 can be provided in a clam shell configuration to define twohandle portions 92 a, 92 b. The handle assembly 92 can further include aspring 36, operatively coupled with the toggle mechanism 80. The needle90 extends from a distal end or tip 91 to a proximal end 93 operativelycoupled to the toggle mechanism 80. The needle 90 can include a washer49 a attached thereto and adapted to abut a proximal end of the spring49, with the needle 90 extending through the spring 49.

The tubular member 94 is configured to cover or surround the portion ofthe needle 90 extending out from the handle assembly 92. A proximal end94 a of the tubular member 94 is disposed within the handle assembly 92to secure it in a generally stationary position, with the needle 90slidable within the tubular member 94. The tubular member 94 can includea barb guard 96 at its distal end 94 b, with the distal end 91 of theneedle 90 adapted to extend out from and retract into the distal end 94b.

In general use of certain toggle mechanism embodiments, the needle tip91 is initially in an extended/engageable position (FIGS. 19-20). Assuch, the anchor 16, e.g., a soft tissue anchor, can be inserted,fitted, snapped, or otherwise coupled to the tip 91 (FIG. 19). Asstated, a mesh, sling or support device or structure 17 can be connectedwith the tissue anchor 16 (FIGS. 17-18). The needle 90, tip 91, andtissue anchor 16 are inserted into the pelvic region of a patient to atarget tissue location where the anchor 16 can be inserted into orthrough the target tissue. The user can then activate or engage theactuator 84 (e.g., clicker or toggle button) which, in turn, causes theneedle 90 to retract to decompress the biasing member 36. Thisdecompression further withdraws the needle tip 91 from its initialextended position (FIG. 21, shown without the barb guard). At a point inthe retraction, the tip 91 withdraws through the anchor bore 60, therebydisengaging or pulling away from the anchor 16, leaving the anchor 16 inthe target tissue with the mesh, sling or other support device 17 orstructure anchored. An audible click or reverb in the handle 92 canprovide an indication to the user that the anchor 16 and needle tip 91are disengaged. This process can be repeated for multiple anchor 16insertions and target tissue anchoring procedures.

Various surgical introducer needle and anchor systems disclosed herein,otherwise known and/or previously incorporated by reference, can includevarious mechanisms, features or devices configured to provide increasedreliability and usefulness in retaining and releasing an implant anchor.Various embodiments of the anchor systems of the present invention caninclude hard stop wedge devices, cut-away snap fit devices, split needletip wedge devices, tube and wedge lock devices, locking barb devices,snap fit devices, squeeze-lock devices, limited press fit devices,one-sided and regional press fit devices, and the like devices orconfigurations.

Exemplary anchor systems 100, as generally illustrated in FIGS. 22-39,can include an anchor 101 having an internal channel or bore 102extending from a proximal end 104 toward a distal end 106 along at leasta portion of the total longitudinal length of the anchor 101. Theinternal channel 102 is capable of receiving a distal end (e.g., needleor wire tip) of an elongate needle 110 of an insertion tool to allow theanchor, such as a self-fixating tip, to be pushed into position withinpelvic tissue during an implant procedure. Such anchor systems 100provide security so that the anchor 101 will not easily detach ordisengage from the needle during insertion, while still allowing foraccurate placement and detachment of the anchor from the needle duringdeployment of the anchor, e.g., within soft tissue within the pelvicregion of a patient.

FIG. 22 depicts an embodiment of the anchor system 100 having a hardstop and wedge feature 120 adapted to interlock the needle 110 and theanchor 101 for selective engagement and disengagement. The anchor 101can include an abutment surface 103. The wedge 120 slides within acorresponding indent or notched travel path 121 within the needle 110 tocreate a hard stop interference to hold the anchor 101 in place andprovide for selective release upon activation. The wedge 120 can beoperatively coupled to the needle, a wire disposed within the needle, orto the anchor, for corresponding sliding to facilitateengagement/disengagement of the needle 110 with the anchor 101. Invarious embodiments, the needle instrument can be constructed ofstainless steel or other compatible materials, while the anchor can beconstructed of various materials, such as polypropylene, biocompatiblemetals, ceramics, polymers in general and resorbable polymers.

FIGS. 23-24 depict an embodiment of the anchoring system 100 having acut-away snap fit feature 124 adapted to interlock the needle 110 andanchor 101 for selective engagement and disengagement. The feature 124can include a protrusion 124 a along a portion of the anchor 101 or bore102 capable of snap engagement with a corresponding indent or notch 125in the needle 40. FIG. 24 depicts an embodiment of the feature 124, withthe protrusion 124 a provided a distance from the distal tip of theanchor 101 to create more flex and thereby facilitate snap engagement.

FIGS. 25-26 depict an embodiment of the anchoring system 100 having asplit needle tip 110 and wedge feature 130 adapted to interlock theneedle 110 and anchor 101 for selective engagement and disengagement.This embodiment can include a needle 110 with a split therealong and aslidable wedge 132 provided such that pulling back on the wedge spreadsthe needle proximate its distal end. This, in turn, spreads the end ofthe needle 110 to hold the anchor 101 in place. Reversal of the stepscan likewise release the hold on the anchor 101, allowing selectiverelease of the anchor from the needle. The wedge 132 can be operativelycoupled to a pull device in the system, including a wire, suture, orother coupled member.

FIGS. 27-28 depict an embodiment of the anchoring system 100 having atube and wedge feature 138 adapted to interlock the needle 110 andanchor 101 for selective engagement and disengagement. The wedge 139 isattached or otherwise provided along a portion of a tubing member 140,as part of the needle system 110. As such, relative movement of theneedle 110 to the tubing 140 drives the movement of the wedge 139 in agroove 141 of the needle 110. This movement of the wedge 139 providesfor selective engagement of the anchor 101 with the needle 110. Anattachment member 143 can couple the tubing 140 and the wedge 139 tofacilitate movement of the wedge 139. Further, the attachment member 143can reside and/or travel in a groove 144.

FIGS. 29a-31b depict an embodiment of the anchoring system 100 having alocking barb and guard feature 148 adapted to interlock the needle 110and anchor 101 for selective engagement and disengagement. The barbfeature 148 can include barbs or tabs 150, or other protrusions, along adistal portion of the needle 110, with the barbs 150 adapted toselectively engage corresponding indent features 151 in the anchor 101for selective engagement of the anchor 101 with the needle 110. Othervariations on the barb and guard feature 148 are disclosed as well. Forinstance, the embodiments of FIGS. 31a-31b can further include arelatively flexible guard feature 148 tending to remain in an openposition (FIG. 31a ). A tube member 152 can be included such that whenthe tube 152 is slid forward, the barb guard feature is moved into aclosed position to engage the barbs 150 with the anchor indents 151 orother portions of the anchor (FIG. 31b ),

FIGS. 32a-32c depict an embodiment of the anchoring system 100 having asnap fit feature 156 adapted to interlock the needle 110 and anchor 101for selective engagement and disengagement. The anchor 101 can includeprotrusions 158, tabs, or like features adapted to engage withcorresponding indent or groove features 160 in the needle 110.Alternatively, the protrusions 158 can be provided along a portion ofthe needle 110, with the anchor 101 including engageable indent orgroove features 160. Other variations on the snap fit feature 156 aredisclosed as well, where the protrusions 158 in the anchor 101 orprovided or formed through a molding process (e.g., formation with acore pin and/or with a mold portion or half).

FIGS. 33-34 depict an embodiment of the anchoring system 100 having asqueeze lock feature 164 adapted to interlock the needle 110 and anchor101 for selective engagement and disengagement. The squeeze lock feature164 can include a wire 166, or other mechanism, such that the tip of theneedle 110 expands under applied tension. This expansion provides a holdon the anchor 101 (FIG. 34). When the tension is released, the needletip returns to its relaxed state, allowing the anchor 101 to slide offof the needle 110 (FIG. 33).

FIG. 35 depicts an embodiment of the anchoring system 100 having alimited press fit feature 170 adapted to interlock the needle 110 andanchor 101 for selective engagement and disengagement. The limited pressfit feature 170 can be limited to structure, e.g., a step feature 172,along a limited or predefined length of the needle 110. As such, an endlength of the distal needle tip 110 can be sized to provide for a slipflit within the anchor 101, while another predefined length or feature172 includes a slightly larger diameter or width to provide pressfitting with the anchor 101. This, in turn, allows for selectiveengagement of the anchor 101 with the needle 110.

FIGS. 36-38 depict an embodiment of the anchoring system 100 having apress fit feature 176 adapted to interlock the needle 110 and anchor 101for selective engagement and disengagement. In one embodiment, the pressfit feature 176 is limited to one side or region of the needle 110 suchthat the added thickness creates a press fit when engaged with theinternal channel 102 of the anchor 101. Other variations of the pressfit feature are disclosed as well, including internal ribs 182 and otherstructures 180 within the anchor channel to provide for selectiveengagement of the anchor 101 with the needle 110. In FIG. 36, forinstance, the press fit feature 176 is provided only on one side orregion of the needle 110, rather than around the needle 110circumference. FIG. 37 discloses a press fit feature 176 including aprotrusion or tab 180 provided within the internal channel 102 of theanchor to facilitate press fitting to the needle 110. FIG. 38 disclosesa press fit feature 176, wherein the internal channel 102 of the anchor101 includes a plurality of ribs 182 to facilitate press fitting to theneedle 100.

The systems 10, 100 and their various components, structures, features,materials and methods may have a number of suitable configurations asshown and described in the previously-incorporated references.

A variety of materials may be used to form portions, structures orcomponents of the systems 10, 100 described herein, including nitinol,polymers, elastomers, thermoplastic elastomers, metals, ceramics,springs, wires, plastic tubing, and the like.

All patents, patent applications, and publications cited herein arehereby incorporated by reference in their entirety as if individuallyincorporated, and include those references incorporated within theidentified patents, patent applications and publications.

Obviously, numerous modifications and variations of the presentinvention are possible in light of the teachings herein. It is thereforeto be understood that within the scope of the appended claims, theinvention may be practiced other than as specifically described herein.

The invention claimed is:
 1. A surgical needle device, comprising: aneedle including a lumen, a proximal portion, and a wire disposed in andtraversable along at least a portion of the lumen; and a handle assemblyincluding a depressible actuator and a body portion, the depressibleactuator having an elongate portion, and integral angled portions, andthe body portion having a longitudinal axis, a proximal portion, adistal portion, and a side surface, the distal portion having opposingside channels and a curved end portion, with the distal portion coupledto the proximal portion of the needle, wherein the depressible actuatoris in operative communication with a portion of the wire such that theintegral angled portions extend distally beyond the curved end portionaway from the needle and the elongate portion traverses within thehandle assembly such that the depressible actuator traverses generallylinearly along the longitudinal axis within the opposing side channelsand toward the proximal portion.
 2. The device of claim 1, wherein adistal portion of the needle receives an anchor device.
 3. The device ofclaim 2, wherein the anchor device includes one or more extending tinesto facilitate soft tissue engagement.
 4. The device of claim 1, whereina distal portion of the needle includes a barb guard to abutably receivean anchor device.
 5. The device of claim 1, wherein the distal portionof the needle includes a curved length.
 6. A surgical implant system,comprising: a sling implant having opposing end portions and a supportportion, and at least one anchor provided at one of the opposing endportions; an implant introducer tool including; a needle having agenerally straight length, a lumen, a distal portion, and a wireextending through and traversable along at least a portion of the lumenfor selective engagement with the at least one anchor; and a handleassembly having a body, opposing channels extending out from the body,and at least one depressible actuator integral with an elongate memberand operatively connected with the wire, the body having a distal endportion, a proximal end portion, and a side portion, the distal endportion having a curved end surface, wherein the generally straightlength of the needle extends out from the distal end portion of the bodyand the at least one depressible actuator angles out from the sideportion, extends out distally past the curved end surface, and isretractable a distance back into the distal end portion of the body,with the elongate member housed and traversable generally linearly andlongitudinally within the body of the handle assembly such that the atleast one depressible actuator traverses within the opposing channelsaway from the distal end portion and toward the proximal end portion. 7.The system of claim 6, wherein the at least one anchor includes one ormore extending tines to facilitate soft tissue engagement.
 8. The systemof claim 7, wherein the distal portion of the needle includes a barbguard to abutably receive the at least one anchor.
 9. The system ofclaim 6, wherein the at least one depressible actuator includes firstand second actuators angling out from the distal end portion of the bodyat an angle less than ninety degrees relative to the generally straightlength of the needle.
 10. The system of claim 6, wherein a portion ofthe needle includes a generally curved length.
 11. The system of claim6, wherein the at least one anchor includes an anchor device provided ateach of the opposing end portions of the sling implant.
 12. The systemof claim 6, wherein the sling implant is constructed at least in part ofa polymer mesh material.
 13. The system of claim 6, wherein the distalportion of the needle includes a barb guard having an angled barbsurface, and the at least one anchor has an angled anchor surface thatabuttably seats with the angled barb surface.
 14. The system of claim 6,wherein a distal tip of the wire extends through and out of the at leastone anchor.